Sleep Apnea Machine Recall: What Luna G3 APAP Users Need to Know

A sleep apnea machine used by thousands of Americans has been placed under a Class I recall, the FDA's most serious recall classification, because a software defect can cause the machine to shut down and stop delivering therapy while it is being used.

The recall involves the BMC Luna G3 APAP, model LG3600, but there is an important distinction consumers need to understand: this does not mean every Luna G3 machine is defective, and it does not apply to every CPAP or APAP machine.

Here is what we know.

What Is Being Recalled?

The affected product is:

Brand: BMCDevice: Luna G3 APAPModel: LG3600Affected firmware: G3-2.00.76Corrected firmware: G3-2.00.77UDI numbers: 06948538363331 and 06948538365892

The affected devices were manufactured between September 11 and October 18, 2024 and ultimately distributed nationwide.

BMC retrospectively reported a recall involving 20,160 Luna G3 APAP devices.

But that number needs context.

BMC says those 20,160 machines had undergone a firmware upgrade at the U.S. importer's warehouse from version G3-2.00.76 to corrected version G3-2.00.77.

After the recall was reported, however, BMC determined that potentially as many as 196 machines may not have received that upgrade.

Those machines may still contain firmware G3-2.00.76.

So when you see headlines saying roughly 20,000 sleep apnea machines have been recalled, do not automatically interpret that to mean 20,000 machines currently contain the dangerous software.

The larger number represents the population involved in the corrective action. BMC says up to 196 units may have missed the correction.

What Can Go Wrong?

Firmware is software built into a medical device that helps control how the machine operates.

According to the FDA recall notice, the defective firmware can cause a problem when three conditions occur simultaneously:

• high pressure,

• a high respiratory rate, and

• high peak airflow.

Under those conditions, the machine may display an “Error” message and then automatically shut down.

That shutdown means the machine stops delivering the prescribed positive airway pressure therapy.

For someone relying on PAP therapy during sleep, loss of therapy is not simply an inconvenience. It is the reason the FDA classified this recall as Class I.

What Does “Class I Recall” Mean?

FDA uses three recall classifications based on the potential health hazard: Class I, Class II and Class III.

Class I is the most serious.

The FDA defines a Class I recall as one in which there is a reasonable probability that use of or exposure to the affected product could cause serious adverse health consequences or death.

That classification describes the potential seriousness of the hazard. It does not mean deaths have occurred.

In fact, BMC reported that, as of its FDA announcement, it had received no complaints or reports of serious adverse events associated with this particular firmware failure.

That distinction matters.

How Is an APAP Different From a CPAP?

You may hear CPAP used casually to describe many sleep-apnea breathing machines, but CPAP and APAP are not exactly the same.

CPAP, or continuous positive airway pressure, generally delivers air at a prescribed pressure while you sleep.

APAP, or automatic positive airway pressure, can automatically adjust pressure within a prescribed range in response to breathing needs.

The recalled LG3600 is the Luna G3 APAP.

The recall does not mean all CPAP machines, all APAP machines, or even all Luna devices are affected.

Consumers should check the exact model and firmware rather than relying only on the appearance or brand of the machine.

An Earlier FDA Warning Adds Important Context

There is another part of this story that deserves attention.

In a May 20, 2026 warning letter to BMC Medical, the FDA discussed this same Luna G3 APAP firmware problem.

FDA said the firmware defect could cause the machine to unexpectedly shut down during use and result in loss of therapy for people with obstructive sleep apnea.

The agency also said the firmware update from G3-2.00.76 to G3-2.00.77 qualified as a medical-device correction or removal that should have been reported to FDA.

According to the warning letter, BMC had not submitted the required Report of Correction or Removal as of May 19, 2026.

The company later retrospectively reported the recall to FDA in July 2026. FDA classified it as a Class I recall in August, and the public recall announcement was published September 8.

That timeline is worth knowing because consumers were not initially notified about the warehouse corrective action.

Do You Have One? Here Is How to Check

First, check the machine itself.

Look for:

Luna G3 APAPModel LG3600

The serial number, or SN, can be found on the label on the back of the machine.

BMC has established an online serial-number lookup that allows owners to enter the serial number and determine the firmware associated with their device.

The FDA also recommends that users consult their physician and Durable Medical Equipment provider, often called a DME provider, to confirm whether their Luna G3 APAP is safe to use.

React Health is the U.S. importer of the affected machines.

Consumers can contact React Health regarding replacement at:

Phone: 863-226-6285Email: 3B-Recall@reacthealth.com

BMC can also be contacted at:

Email: bmc-recall@bmc-medical.com

What If Your Machine Has Firmware G3-2.00.76?

This is where the instructions become specific.

According to the FDA recall notice, an affected Luna G3 APAP operating with firmware G3-2.00.76 should be discontinued immediately until a replacement device is provided.

That instruction applies to the affected device and firmware.

It is not a recommendation for people using other CPAP or APAP machines to stop their prescribed therapy.

Anyone uncertain about the machine they use should check the model and serial number and contact the prescribing healthcare provider or DME supplier.

The Maria Approved It Bottom Line

Do not panic. Check.

This is a serious recall because an affected machine can shut itself down and stop delivering therapy. But the details matter.

The recall concerns one specific model:

BMC Luna G3 APAP LG3600

And the software consumers need to identify is:

Firmware G3-2.00.76

BMC says it upgraded the 20,160 devices involved in the original corrective action, but later found that potentially up to 196 machines may have missed that upgrade.

If you use a Luna G3, do not assume it is affected and do not assume it is safe simply because it still turns on.

Check the model.Check the serial number.Check the firmware.

And if it contains the affected firmware, follow the FDA recall instructions and contact your provider about replacement.

Maria Approved It will continue monitoring this recall for additional FDA or manufacturer updates.

Sources: U.S. Food and Drug Administration recall announcement, September 8, 2026; FDA Medical Device Recall Database; FDA warning letter to BMC Medical Co., Ltd., May 20, 2026.